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510(k) K012585

AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE by Ameditech, Inc. — Product Code LAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2001
Date Received
August 10, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

Other clearances by Ameditech, Inc.

  • K113501 — AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) (December 5, 2011)
  • K113046 — AMEDITECH IMMUTEST MILTI-DRUG SCREEN (November 10, 2011)
  • K063015 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 (December 20, 2006)
  • K053175 — AMEDITECH DRUGSMARTCUP (December 8, 2005)
  • K050186 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III (March 4, 2005)
  • K042975 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II (December 29, 2004)
  • K040092 — AMEDITECH IMMU TEST DRUG SCREEN PANEL (March 8, 2004)
  • K023126 — AMEDITECH IMMUTEST HCG PREGANCY TEST (November 18, 2002)
  • K012484 — AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE (November 30, 2001)
  • K012483 — AMEDITECH IMMUTEST DRUG SCREEN OPIATES (November 30, 2001)

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  • K133047 — RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET (December 18, 2014)
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